QWZ
- Product code
- QWZ
- Device name
- Prognostic Test For Assessment Of Chronic Kidney Disease Progression
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.1223
- Medical specialty
- Clinical Chemistry
- Marketing pathway
- 510(K)
- 510(k) clearances (all years, FDA)
- 1 (all years; only the last 3 years are listed here)
FDA classification definition
A prognostic test for assessment of chronic kidney disease progression is an in vitro diagnostic device intended to measure one or more analytes obtained from human samples as an aid in assessing the risk for progression of chronic kidney disease. This device is not intended for diagnosis of any disease, for serial monitoring of kidney disease progression, or for monitoring the effect of any therapeutic product.
Official FDA classification page: QWZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).